Medical Expulsive Therapy for Ureter Stone Using Naftopidil

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Ureter Stones

Treatments: Drug: Placebo for Naftopidil; Drug: Naftopidil 75mg; Drug: Standard treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01952314

SNUBH-URO-2012-03

SNUBH-URO-2012-03-MET (Other Identifier)

Details and patient eligibility

About

This study is to investigate whether naftopidil is effective or not for the spontaneous passage of ureteral stones with sizes of 3 to 10 mm.

Full description

1. Enrollment

   1. patients with ureteral stones of sizes from 3 to 10 mm
   2. patients aged more than 18 years

2. Randomization

   1. naftopidil 75 mg qd for 14 days or placebo
   2. Standard treatment with pain-killers were also applied.(aceclofenac)

3. Follow-up for 28 days

   1. We confirm the stone free status by CT or X-ray films at 14th and 28th days.
   2. Rates of active treatment will be also evaluated.

Enrollment: 150 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >= 20 years
• single 3 to 10 mm ureter stone (longest diameter)

Exclusion criteria

• Presence of multiple ureter stones
• Renal insufficiency (serum Cr > 1.4 mg/dL)
• Febrile urinary tract infections(fever > 38°C, evidence of urinary infection)
• pregnancy or breast feeding
• solitary kidney
• hypersensitivity to naftopidil
• current use of any alpha-blocker, calcium-channel blocker, corticosteroid (within 4 weeks)
• moderate or severe cardiovascular or cerebrovascular disease
• hepatic dysfunction (>2 x normal upper limit)
• significant active medical illness which in the opinion of the investigator would preclude protocol treatment
• Genetic disorder such as Galactose intolerance, Lapp Lactase deficiency, Glucose-Galactose malabsorption

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Control groups with only analgesics

Placebo Comparator group

Description:

Control groups will receive only analgesics.

Treatment:

Drug: Standard treatment

Drug: Placebo for Naftopidil

Naftopidil

Active Comparator group

Description:

This interventional group will receive analgesics and naftopidil 75mg po qd.

Treatment:

Drug: Standard treatment

Drug: Naftopidil 75mg